Study of Patient Use and Perception of the Travatan Dosing Aid

Wills Eye

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Device: Partially functional monitoring device; Device: Fully functional monitoring device; Device: Non-functional monitoring device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00626067

CMS-06-09 (Other Identifier)

IRB #06-762E

Details and patient eligibility

About

The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.

Full description

Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):

1. Fully functional Travatan compliance monitor
2. Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
3. Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.

At end of study, patients fill out questionnaire assessing

1. Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
2. patient's belief as to whether their compliance was monitored or not

Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.

The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Open angle glaucoma or ocular hypertension
• Presently using Travatan eye drops

Exclusion criteria

• Allergy to prostaglandin

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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45 participants in 3 patient groups

1 Fully functional monitoring device

Active Comparator group

Description:

Fully functional monitoring device

Treatment:

Device: Fully functional monitoring device

2 Partially functional monitoring device

Active Comparator group

Description:

Partially functional monitoring device

Treatment:

Device: Partially functional monitoring device

3 Non-functional monitoring device

Sham Comparator group

Description:

Non-functional monitoring device

Treatment:

Device: Non-functional monitoring device